Brent Vose, Vice President and Head of Oncology at AstraZeneca commented, "The approval of IRESSA in Australia offers great hope to thousands of lung cancer patients and their families. Australia is the second country to approve IRESSA, and we look forward to a similar outcome in a number of other countries, where regulatory reviews are underway, so that this important new treatment can be made available to the patients who suffer from the devastating results of advanced lung cancer."

The approval in Australia reflects both confidence in IRESSA and a recognition of the critical need for new treatment options for NSCLC - a complex, severely symptomatic illness with a devastating impact on the patient and their family. In the year 2000 there were over 1.2 million people diagnosed with lung cancer world-wide and more than 1 million people died from the disease. In the region of South-East Asia, there were over 65,000 new cases (of which 8,157 were reported in Australia) and 60,599 deaths (6,938 in Australia) from lung cancer. The worldwide market for NSCLC is valued at $1.6 billion, and is forecasted to grow to $8 billion by 2011.

The approval in Australia is based on data from two large, randomised Phase II trials, IDEAL 1 and IDEAL 2 (IRESSA Dose Evaluation in Advance Lung Cancer). These studies demonstrated that taking one tablet of IRESSA 250mg per day monotherapy provided clinically-significant anti-tumour activity in patients with previously treated advanced NSCLC.

The effectiveness of IRESSA is based on objective response rates. Most responses were seen in the first eight weeks of treatment and at least 40 per cent of patients gained clinical benefit and improvement in their disease-related symptoms. Approximately 30 per cent of patients taking IRESSA were alive after one year of commencing treatment. IRESSA is a once-a-day 250 mg pill and is not typically associated with the severe side-effects often seen with standard cytotoxic chemotherapy treatments used to treat NSCLC patients. Most patients experience some side-effects but these are generally mild and well-tolerated including rash and diarrhoea. Interstitial Lung Disease (ILD) is a known complication of lung cancer and has been observed in patients taking IRESSA in about 1 per cent of patients.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.